Effects of the Specific Supplementation (100% Seric Hydrolized Lactoprotein and MCT) in Malnourished Oncologic Patients Undergoing Radiotherapy
试验速览
- 阶段
- 不适用
- 状态
- Enrolling By Invitation
- 发起方
- 入组人数
- 132
- 试验地点
- 4
- 主要终点
- Percentage of patients who improve the degree of malnutrition.
研究概览
简要总结
An observational, prospective, multicenter study to be conducted in 5 hospitals in Spain. Patients with cancer undergoing radiotherapy are malnourished or at risk of malnutrition. Due to the characteristics of their pathology or gastrointestinal disorders, the use of oligomeric nutritional formulas formulated with 100% hydrolyzed whey lactoprotein and a high MCT content is recommended as part of routine clinical practice. Patients will be followed for 12 weeks, with three visits: a baseline visit upon inclusion in the study, after 6 weeks and a final visit 12 weeks after the nutritional treatment starts.
详细描述
The prevalence of malnutrition is high in cancer patients: about 80% of patients will suffer from malnutrition at some point, and it is the cause of 10-20% of deaths in this type of patient.
To address malnutrition in these patients, international clinical guidelines recommend periodically reviewing their nutritional status and supplementing with oral nutrition formulas (ONS) when they are unable to meet their nutritional needs from their usual diet.
The ONSs have a nutrient composition designed to meet the specific needs of the patient, but there are pathologies, types of tumours and treatments, such as radiotherapy, chemotherapy, immunotherapy and others that can alter the digestion process, making it difficult for the gastrointestinal tract to utilise nutrients. Patients with these pathologies often cannot tolerate polymeric SNO formulations and require oligomeric peptide-based diet (PBD) formulations.
PBDs contain hydrolysed proteins in the form of peptides and medium-chain triglycerides (MCTs), which are more easily assimilated, helping patients to reduce weight loss and improve overall nutritional status. In addition, they contain hydrolysed serum lactoprotein with high biological quality that stimulates the formation of muscle tissue, minimising cachexia.
Radio/chemotherapy/immunotherapy treatment has negative effects on the nutritional and functional status of cancer patients, which also makes them more susceptible to the toxicities of cancer treatments and clinical complications. It has been shown that these patients tolerate PBD formulas well and even reduce their baseline intestinal symptoms, which facilitates compliance with nutritional treatment. However, adherence to these treatments remains a challenge as it is not always optimal, resulting in the non-achievement of the potential benefits.
研究设计
- 研究类型
- Observational
- 观察模型
- Cohort
- 时间视角
- Prospective
入排标准
- 年龄范围
- 18 Years 至 —（Adult, Older Adult）
- 性别
- All
- 接受健康志愿者
- 否
入选标准
- •Patients of legal age (≥18 years).
- •Oncology patients (with head and neck, lung or rectal cancer) undergoing or about to start radiotherapy treatment. Patients with oesophageal cancer will also be included, as long as the patient is not undergoing PEG.
- •Patients who are malnourished or at risk of malnutrition according to GLIM criteria.
- •Patients requiring supplementation with an oligomeric formula with 100% hydrolysed serum lactoprotein and high MCT intake due to gastrointestinal disturbances (either maldigestion or maldigestion, malabsorption or dysmotility) intolerance to polymeric formulations or any other reason as considered by the physician.
- •Patients who, at the discretion of the investigator, have the ability to answer the questionnaires and follow the procedures detailed in the protocol.
- •Patients who give written informed consent to participate.
排除标准
- •Patients with galactosemia, allergies and/or intolerances to lactose or any of the compounds of the formula.
- •Patients receiving nutritional support other than that of the study characteristics or who have received it during the last month. It will be accepted in patients who, being on a polymeric SNO, are advised to change to the oligomeric formula under study, due to gastrointestinal alterations, intolerances or any other reason considered by the doctor.
- •Patients who have undergone surgery in the last three months.
- •Patients who have received Enteral Nutrition in the last 3 months for SNG/SNJ/PEG.
- •Pregnant or lactating women.
- •Patients with advanced renal or hepatic disease (with creatinine clearance less than 45 ml/min or CP=C).
- •Patients with advanced neoplastic disease with life expectancy <3 months.
结局指标
主要结局
Percentage of patients who improve the degree of malnutrition.
时间窗: From enrollment to the end of treatment at 12 weeks
According to body weight, after 12 weeks of treatment with SNO with 100% hydrolyzed serum lactoprotein and high MCT intake.
次要结局
- Percentage of patients with improvement in the degree of malnutrition(From enrollment to the end of treatment at 12 weeks)
- Percentage change in BMI(From enrollment to the end of treatment at 12 weeks)
- Arm circumference(From enrollment to the end of treatment at 12 weeks)
- Calf circumference(From enrollment to the end of treatment at 12 weeks)
- Maximum prehensile strength value(From enrollment to the end of treatment at 12 weeks)
- Sit-to-stand test(From enrollment to the end of treatment at 12 weeks)
- Impedancemetry values(From enrollment to the end of treatment at 12 weeks)
- Percentage of patients presenting complications associated with nutritional status during treatment.(From enrollment to the end of treatment at 12 weeks)
- Percentage of patients presenting changes in gastrointestinal tolerance after 6 and after 12 weeks of treatment with SNO with 100% hydrolyzed serum(After 6 and after 12 weeks of treatment)
- Distribution of the patients according to their compliance with the treatment(At 6 and 12 weeks of treatment.)
- Distribution of the patients according to their adherence to the treatment(At 6 and 12 weeks of treatment.)
- Percentage of patients who maintain or improve their quality of life after 12 weeks of treatment.(After 12 weeks of treatment.)
- Percentage of patients satisfied with the product(After 12 weeks of treatment with SNO)
- Average health care expenditure per patient, according to degree of malnutrition, during the study.(From enrollment to the end of treatment at 12 weeks)